Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
The primary function of the QS Specialist II is help ensure that departments responsible for the development, manufacturing, and distribution of products are in compliance with local, divisional and corporate procedures, as well as, conforming to the Quality Systems Regulations (21CFR 820), ISO 13485:2003 and other applicable regulations and standards. Collaborate with ADC Whitney, ADC Alameda and ADC Donegal to establish and maintain division level processes. Additional primary goal is to ensure that policies, procedures and processes are in place so that all Quality Systems activities meet applicable regulations.
Manage policy integration from other Abbott site documents into ADC document systems.
Assists management in the standardization and simplification of documenting processes.
Act as primary contact for new releases of corporate policies. Responsible for disseminating the new policies to all concerned parties, assessing gaps and updating division procedures to maintain alignment with corporate requirements.
Compiles the division comments on draft policies and provides consolidated response to corporate.
Provides project management for quality plan activities.
Responsible for implementing and maintaining the effectiveness of the quality system.
Participates with the Director of Quality Systems in the deployment and improvement of Quality Systems throughout the Division.
Measures and reports progress against quality goals.
Pro-actively investigates, identifies, and implements best in class Quality System practices.
Quality Systems Training Coordinator:
Work with area manage to ensure that all training assignments for Quality Systems positions are accurate.
Works with Director of Quality Systems to prepare and conduct required QS Management reviews.
Includes the preparation of the presentation, meeting minutes and follow up on action items.
Work closely with the QS and Compliance groups to set business strategy.
Must ensure that future applications meet both ADC business needs as well as Regulatory requirements
Lead cross site project improvement initiatives in establishing global ADC processes and systems.
This position requires an Associates degree or 5-7 years Medical Device experience in Quality Functions Knowledge of regulations and standards affecting In Vitro Diagnostics and Medical Devices (CFR 820) (e.g. ISO, FDA Quality System Regulations preferred). Candidates will have experience utilizing basic negotiation, influencing and conflict management skills, will interact effectively with peers and leadership across departments and possess excellent interpersonal and communication skills.